First patient dosed in the Phase I clinical trial of PulseSight Therapeutics’ PST-611 treatment for dry AMD/Geographic Atrophy

PARIS, July 07, 2025 (GLOBE NEWSWIRE) -- PulseSight Therapeutics SAS, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology, is pleased to announce that the first patient has been successfully dosed in its Phase I clinical trial (PST-611-CT1) aiming to assess safety and tolerability of its lead program, PST-611, in humans.

PST-611 is a first-in-class non-viral vectorized therapy for the treatment of dry Age-related Macular Degeneration (AMD) /Geographic Atrophy (GA), expressing human transferrin, a highly potent iron regulator, playing a central role in restoring normal iron homeostasis.

AMD is the leading cause of central vision loss in the elderly, affecting 200 million people worldwide. AMD's pathogenesis is complex, and the disease still represents a high unmet medical need. Dry AMD involves the dysregulation of iron homeostasis, leading to an excess of free iron causing highly toxic effects such as inflammation, oxidative stress, and ultimately retinal cell death (ferroptosis).

PST-611-CT1 is a first-in-human single ascending dose study that aims to establish, in six to a maximum of 12 dry AMD/GA patients, the safety profile of the drug and validate the maximal tolerated dose in view of the following Phase IIa proof-of-concept trial. Preliminary results are anticipated early 2026, subject to patient recruitment.

The study is being conducted in Paris and Grenoble by Professor Francine Behar-Cohen, MD, PhD at the Department of Ophthalmology, Cochin – Assistance Publique-Hôpitaux de Paris (AP-HP), the inventor of our technology, and Professor Christophe Chiquet, MD, PhD at the Department of Ophthalmology, CHU Grenoble Alpes.

Professor Francine Behar-Cohen declared, “Having pioneered the development of the electro-transfection technology that delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle of the eye, I am very excited to move PST-611, expressing transferrin, into its first clinical trial. Late-stage dry AMD/ GA is a progressing disease that leads to vision loss and for which we have no therapeutic options for our patients. Based on its mechanism of action and thanks to the innovative delivery technology, PST-611 has potential to become a major treatment option for these patients.”

Judith Greciet, CEO of PulseSight Therapeutics said, “The dosing of the first patient in our PST-611-CT1 trial is a very exciting milestone for the company. Supported by the previous clinical demonstration of the safety profile of our innovative delivery technology and a solid pre-clinical package, we believe PST-611 holds the potential to improve both anatomical and functional features of dry AMD/GA. Moreover, the sustained and long-lasting expression of transferrin should help reduce the need for frequent reinjections, strongly improving patients’ compliance to the treatment. Once the safety and the maximal dose are confirmed, our goal is to swiftly move into a phase IIa proof-of-concept study, to demonstrate the ability of transferrin to protect retinal cells from atrophy and preserve vision.”

Media contact

Sue Charles, Charles Consultants

T: +44 (0)7968 726585

E: sue@charles-consultants.com

About Age-related Macular Degeneration (AMD)

AMD develops with aging. It is a disease with progressive, painless loss of central vision with a strong burden on patients’ everyday life, impacting their ability to read, recognize faces and see objects, and is ultimately leading to irreversible central vision loss. Dry AMD is the most common form of AMD, progressing through successive stages into the late form of dry AMD also called geographic atrophy (GA). Wet AMD is a less common type of late AMD causing faster vision loss. Any stage of dry AMD can turn into wet AMD. In all its forms, AMD represents a compelling unmet need for more effective and durable treatment options, with a large and growing market, estimated to reach $27.5 Billion by 2031.

About PST-611 for GA

PST-611 encodes the human transferrin protein, a crucial regulator of iron homeostasis and holds the potential to effectively address key pathological mechanisms in dry AMD/GA, whilst requiring re-treatment only every four to six months. This program is expected to enter the clinic by late summer 2025.

About PulseSight Therapeutics

PulseSight is a clinical-stage biotech company committed to developing disruptive non-viral vectorized therapies with minimally invasive delivery technology to protect and improve the vision of patients with retinal disease with a focus on age-related macular degeneration (AMD) including wet AMD and geographic atrophy (GA) secondary to dry AMD.
Already clinically validated for its safety and sustained activity, PulseSight’s technology platform delivers DNA plasmids encoding therapeutic proteins into the ciliary muscle using an electro-transfection system. The ciliary muscle cells act as biofactories, expressing therapeutic proteins that reach the retina with high distribution, providing a safe and long-lasting treatment for major eye diseases.

Based in Paris, France, PulseSight’s investors are Pureos Bioventures, ND Capital and Korea Investment Partners (KIP).

For more information visit www.PulseSightTherapeutics.com

Watch the video of the technology here: www.PulseSightTherapeutics.com

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